The Effect of 0.1% Topical Ciclosporin A for 12-weeks on the Eye Surface Immune Cells in Dry Eyes

Launched by THE UNIVERSITY OF NEW SOUTH WALES · Mar 20, 2025

Keywords

ClinConnect Summary

The immune system plays a pivotal role in dry eye disease (DED) pathogenesis. An increased level of several tear cytokines, chemokines, expression of HLA-DR molecules and activation of antigen presenting cells - dendritic cells (DCs), and lymphocytes all plays a central role in DED pathogenesis . The increased expressions of CD4+ and CD8+ T cells in the ocular surface of DED patients suggest a potential role of adaptive immunity in DED chronicity. The presence of antigen-presenting cells in the ocular surface and the upregulation of MHC II, IL-2, IL-17, IL-6 and IFN- γ and other co-stimulat...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 years of age and above
• • 2. Participants should meet any two of the following DED diagnostic criteria: i) ocular surface disease index score of ≥23 and ii) Oxford staining score of ≥1 iii) Tear meniscus height \< 0.2 mm.
• Exclusion Criteria:
• • 1. Participants currently using or with previous use of steroids, ciclosporin, lifitegrast or any anti-inflammatory eye drops in the last 6 months.
• • 2. Participants with systemic CsA or tacrolimus
• • 3. Known hypersensitivity or contraindication to the study medication or any of its ingredients.
• • 4. Active intraocular inflammation.
• • 5. Contact lens wear or the use of contact lenses in the last 4 weeks.
• • 6. Active eye infections or history of critical illness.
• • 7. DED secondary to Steven-Johnson syndrome and cicatricial conjunctival disease.
• • 8. Participants with other ocular co-morbidities and medications for glaucoma.
• • 9. Participants with previous history of ocular surgery in the past 6 months.
• • 10. Any other active or inactive systemic condition, structural abnormality such as eyelid malposition's that in the judgment of the investigator could confound study assessments or limit compliance.
• • 11. Pregnant/breastfeeding women

Trial Officials